[EMEA] Director, Distribution
2 weken geleden
Company Description
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
PURPOSE OF ROLE
Requirements
In compliance with any internal and external (GxP, ISO…) applicable requirements, the position holder is accountable, within the EMEA region, for leading and driving Quality oversight of the following activities:
- Distribution operations – all allocated products
- Commercial affiliate operations – all allocated products
- NL-based functions
- Distribution operations – all allocated products
- Commercial affiliate operations – all allocated products
- NL-based functions
- To lead and drive Quality operations for EMEA distribution operations, ensuring:
- Effective and efficient organization to best support the company goals and vision
- Effective implementation of all applicable quality standards, policies and processes
- Development and implementation of robust, efficient, state-of-the art governance, procedures,
- Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
- Effective management of repackaging/reworking/labeling operations, QC importation testing or any other operation needed to support the business
- Identification and effective implementation of appropriate improvement plans
- Proper selection, qualification and quality oversight of third-party distributors and transporters
- Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial
- Appropriate performance management
- To lead and drive Quality operations within the EMEA commercial network, ensuring:
- Effective and efficient organization to best support the company goals and vision
- Effective implementation of all applicable quality standards, policies and processes
- Development and implementation of robust, efficient, state-of-the art governance, procedures,
- All-time inspection readiness, including adequate regulatory inspection preparation, management,
- Effective communication within any local Health Authorities and the country/cluster organization,
- Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial
- Appropriate performance management
- Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
- Identification and effective implementation of appropriate improvement plans
- Proper selection, qualification and quality oversight of third-party service providers (quality
- The right mindset is fostered across the network
- Appropriate quality support and training/education
- To lead quality oversight of NL-based EMEA functions, ensuring:
- Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
- Effective implementation of all applicable quality standards, policies and processes
- Identification and effective implementation of appropriate improvement plans
- The right mindset is foster across those functions
- Appropriate quality support and training/education
- To ensure Santen SA/NL complies with its duties per any applicable license, incl. possible RP/PRRC role
- To represent EMEA Quality in global projects
- To actively participate to the EMEA Quality Leadership Team (QLT) and to lead cross-functional
- To lead, organize, manage, develop, and coach the team, fostering the right behaviors and mindset
- To manage the allocated budget
- M.Sc. education in pharmacy, chemistry, biology, or life science
- Lean Six Sigma Green Belt certification a bonus
- 12-15 years of Quality experience in pharma companies operating globally
- Minimum 5 years of experience in a multi-site or regional corporate quality role with a focus on distribution and country quality
- Thorough knowledge and understanding of any applicable GxP and Medical Device-related requirements and regulations
- Experience in successfully leading cross-functional teams and projects at multi-site or regional level
- Thorough understanding of distribution, and commercial activities
- Significant experience in managing regulatory inspections and interacting with authorities
- Significant experience in managing third-party organizations
- Strong knowledge of risk management approaches and methods
- Exposure to other products and their regulations such as food supplements
- Intercultural sensitivity and awareness
- Knowledge in the use of project management tools
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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